Initiating Pre-Market Clinical Investigations in the EU: What You Need to Know

🔗 Register Now — Free 5-Day Email Crash Course + Masterclass: Pre-Market Clinical Studies in the EU

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🎥 About This Session: Initiating Pre-Market Clinical Investigations in the EU — What You Need to Know

A practical deep dive into how to successfully plan and launch pre-market clinical investigations in the EU under MDR.
Discover how to navigate country differences, identify the right investigators and sites, and streamline approvals for faster study starts.
Learn proven strategies to avoid costly delays and ensure smooth progress from site selection to first patient in — and beyond.

Featuring Daniela Karrer (VP Operations & Clinical Affairs) and Matteo Mosso (Director, Clinical Affairs) from Donawa Lifescience, this masterclass distills over 20 years of EU clinical experience into a clear roadmap you can apply immediately.

💡 Session Highlights
• How to evaluate and select EU investigators and clinical sites strategically.
• Navigating Competent Authority and Ethics Committee submissions.
• Understanding MDR requirements and country-specific variations.
• Avoiding early-stage mistakes that jeopardize enrollment success.
• Building study budgets and contracts that support efficiency.
• Applying early best practices to prevent downstream challenges.

✅ Specific Topics Covered
• Engaging investigators and study teams effectively
• Pilot vs. pivotal study investigator requirements
• Evaluating and selecting clinical sites for strong enrollment
• Submissions to Competent Authorities and Ethics Committees
• Study budget considerations

🎁 BONUS for All Registrants
Receive our exclusive 5-Day EU Clinical Study Email Course, delivered straight to your inbox after the webinar, or click the link below to register
👉 https://members.mlvexchange.com/offer...

👩‍⚕️ Speakers
✅ Daniela Karrer — VP Operations & Clinical Affairs, Donawa Lifescience
✅ Matteo Mosso — Director, Clinical Affairs, Donawa Lifescience

🎯 Who Should Watch
Regulatory, Clinical Affairs, and Project Management professionals in MedTech who are planning or preparing EU pre-market clinical investigations — from startups to established manufacturers navigating MDR requirements.

⏱️ Chapters
(00:00) – Welcome & Kickoff
(00:10) – Ethics Committee Submissions & Overview
(00:37) – About the 5-Day EU Clinical Study Email Course
(00:45) – Early Best Practices & Common Pitfalls
(03:44) – Country Differences & Timelines
(04:21) – Budgeting, Contracts & CTA
(04:50) – Site Selection & Feasibility for Enrollment
(05:19) – Agenda Recap: What You’ll Learn
(05:39) – Investigator Selection Strategy (PI Requirements)
(08:08) – MDR Context for Pre-Market Clinical Investigations
(12:45) – Submissions to Competent Authorities
(14:29) – Pilot vs. Pivotal Requirements
(58:34) – Q&A
(59:56) – Closing & Resources